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Recruiting NCT07470021

Preop US-Guided Nerve Blocks for Pain & Recovery After Ankle Arthroscopy

No phase Interventional Ankle Ligament Injury,Chronic Ankle Instability,Ankle Arthroscopy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultrasound-guided popliteal sciatic and saphenous nerve block, Placebo nerve block.
Who it may be relevant to
Registry conditions: Ankle Ligament Injury,Chronic Ankle Instability,Ankle Arthroscopy. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects of Preoperative Ultrasound-Guided Popliteal Sciatic and Saphenous Nerve Blocks on Early Pain and Functional Recovery After Ankle Arthroscopy: A Randomized, Double-Blind, Controlled Trial

Overview

This randomized, double-blind controlled trial investigates the effectiveness and potential trade-offs of preoperative ultrasound-guided popliteal sciatic and saphenous nerve blocks in patients undergoing ankle arthroscopy, a procedure often performed in day-case settings but associated with significant early postoperative pain and frequent opioid use. The study evaluates whether these nerve blocks can reduce early postoperative pain-measured by the highest NRS score within 24 hours-and examines their impact on functional recovery, including motor strength and ambulation. All patients receive standardized general anesthesia and multimodal analgesia, with outcomes including opioid consumption, ankle weakness, patient satisfaction, range of motion, muscle strength, hospital stay duration, and analgesia-related costs.

Detailed description

Background

Ankle arthroscopy is often performed in day-case or short-stay settings. Despite the minimally invasive incisions, patients frequently experience significant early postoperative ankle pain, often requiring substantial opioid analgesia, which can lead to notable opioid-related side effects. Currently, there is no standardized perioperative analgesic protocol for this procedure, and high-quality evidence is lacking on whether nerve blocks offer a meaningful net benefit in this context.

This study evaluates the net clinical benefit of preoperative popliteal sciatic and saphenous nerve blocks in ankle arthroscopy by assessing their effect on early postoperative pain control and functional mobility. Outcomes are measured through the highest pain scores within 24 hours and assessments of ambulation ability, aiming to inform clinical decision-making regarding perioperative analgesia strategies.

Hypothesis

Compared to sham blocks, preoperative popliteal sciatic and saphenous nerve blocks significantly reduce the highest postoperative pain scores (NRS 0-10) in the recovery room after ankle arthroscopy, but may also result in reduced ankle motor strength and decreased early ambulation ability.

Surgical and Anesthetic Protocol

All patients receive general anesthesia, maintained with propofol and remifentanil according to body weight. Anesthetic depth is titrated to maintain a BIS value between 40-60 while ensuring hemodynamic stability. A standardized dose of 5 mg of tropisetron is administered postoperatively to prevent PONV.

Postoperative analgesia includes celecoxib 200 mg BID and acetaminophen 500 mg every 6 hours, with oxycodone-acetaminophen (325 mg/5 mg) available as rescue analgesia if needed.

Outcome Measures

Highest NRS pain score within 24 hours postoperatively

Total opioid consumption in the first 24 hours

Average pain score at 24 hours post-op

Patient-reported ankle weakness (NRS 1-10)

Patient satisfaction with postoperative analgesia (4-point Likert scale)

Degrees of ankle plantarflexion and dorsiflexion, and MRC muscle strength grading (0-5), assessed pre-block and at discharge

Total hospital stay duration

Total costs related to anesthesia and analgesia

Interventions

  • Procedure Ultrasound-guided popliteal sciatic and saphenous nerve block
    Ultrasound-guided sciatic (20 mL) and saphenous (10 mL) nerve blocks using 0.25% ropivacaine were administered in the prone position before induction. Block success was confirmed via ultrasound (circumferential spread) and sensory loss in relevant ankle dermatomes.
  • Procedure Placebo nerve block
    The control group underwent the same procedure, with an equivalent volume of 0.9% normal saline injected instead of local anesthetic.

Primary outcome measures

  • The patient's highest NRS pain score within 24 hours postoperatively [Time frame: within 24 hours postoperatively]
Secondary outcome measures (4)
  • NRS pain score at 24 hours postoperatively [Time frame: at 24 hours postoperatively]
  • Opioid consumption within 24 hours postoperatively (OME) [Time frame: within 24 hours postoperatively]
  • Patient-reported ankle weakness (0-10 NRS) [Time frame: Within 24 hours after surgery]
  • Ankle plantarflexion and dorsiflexion angles, as well as manual muscle strength graded by the MRC scale (0-5), were assessed before the nerve block and at the time of discharge. [Time frame: Within 24 hours after surgery]

Eligibility criteria

Inclusion criteria

Age between 18 and 65 years

ASA physical status classification I-II

Scheduled to undergo ankle arthroscopy under general anesthesia

Expected to be available for follow-up on the day of surgery (day-case or short-stay surgery)

Able to understand the procedures and methods of the clinical trial and voluntarily provide written informed consent

Body mass index (BMI) between 16 and 32 kg/m²

Exclusion criteria

History of severe ankle nerve injury or peripheral neuropathy

Severe cardiac, pulmonary, hepatic, or renal dysfunction

Chronic pain or regular use of opioid analgesics for more than 3 months

History of extensive ankle or lower leg surgery that may affect nerve localization

Psychiatric disorders or cognitive impairment that preclude accurate NRS pain scoring

Pregnancy or breastfeeding

Known allergy or contraindication to any of the study drugs

Any other condition deemed unsuitable for inclusion by the investigators

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou

Identifiers

NCT: NCT07470021 · 2026-0051

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗